Product Classification

• Device: system, image processing, radiological
• Regulation Description: Medical image management and processing system.
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Product Code: LLZ
• Premarket Review: Office of Radiological Health (OHT8); Division of Radiological Imaging Devices and Electronic Products (DHT8B)
• Submission Type: 510(k)
• Regulation Number: 892.2050
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 12-165 NEMA XR 22-2006 (R2020)
  "Quality Control Manual" Template for Manufacturers of Displays and Workstations Labeled for Final Interpretation in Full-field Digital Mammography
• 12-166 NEMA XR 23-2006 (R2020)
  "Quality Control Manual" Template for Manufacturers of Hardcopy Output Devices Labeled for Final Interpretation in Full-field Digital Mammography
• 12-261 ISO IEC 10918-1 First edition 1994-02-15
  Information technology - Digital compression and coding of continuous-tone still images: Requirements and guidelines [Including: Technical Corrigendum 1 (2005)]
• 12-344 IEC 62563-2 Edition 1.0 2021-11
  Medical electrical equipment - Medical image display systems - Part 2: Acceptance and constancy tests for medical image displays
• 12-349 NEMA PS 3.1 - 3.20 2022d
  Digital Imaging and Communications in Medicine (DICOM) Set
• 12-352 NEMA PS 3.1 - 3.20 2023e
  Digital Imaging and Communications in Medicine (DICOM) Set

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• beanstock consulting
• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc